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LMI 1195-101

Phase 1

Heart Failure | Small molecule | Cardiovascular |Lantheus Holdings, Inc.|Last Updated: Nov 16, 2020

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

LMI 1195-101 · 1 trial · 1 indication

Phase 1 1
NCT00891241A Phase 1 Trial to Determine Dosimetry, Biodistribution and Safety of LMI 1195-101 in Healthy Subjects and Patients With Heart FailureHeart Failure
COMPLETED12 Analytics
PHASE1COMPLETED
A Phase 1 Trial to Determine Dosimetry, Biodistribution and Safety of LMI 1195-101 in Healthy Subjects and Patients With Heart Failure
Heart FailureUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety of LMI 1195 in terms of treatment-related adverse events
14 days

Number of study subjects exhibiting treatment-related adverse events

Secondary Endpoints

Radiation Dosimetry of a single dose of LMI 1195
2 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALHealthy Population
Cohort 2EXPERIMENTALHeart Failure Subjects with a documented ejection fraction of 35% or less, and a diagnosis of NYHA Class II-III heart failure, history of ventricular arrhythmia and ICD placement

Interventions

NameTypeDescription
LMI 1195-101DRUGSingle dose, bolus IV injection of LMI 1195
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersYes
Study Sites2

Cohort 1 Inclusion: * Healthy, age 18-40 Cohort 1 Exclusion: * Significant or chronic medical illness * Pregnant females * Smoking within one month of enrollment * Use of any prescription drugs within 4 weeks prior to dosing Cohort 2 Inclusion: * 30-70 year old subjects with a diagnosis of NYHA...

Countries:United States
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Frequently asked questions about LMI 1195-101

What is LMI 1195-101 used for?

LMI 1195-101 is an investigational small molecule being studied for use in heart failure. It is a cardiovascular therapeutic agent currently in Phase 1 clinical development. The drug is being evaluated for its safety, biodistribution, and dosimetry in patients with heart failure.

Who makes LMI 1195-101?

LMI 1195-101 is being developed by Lantheus Holdings, Inc., a company traded on the NASDAQ under the ticker LNTH. The company is conducting clinical research on this investigational cardiovascular drug for heart failure.

What phase is LMI 1195-101 in?

LMI 1195-101 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. A Phase 1 trial has been completed to evaluate its safety and other early-stage characteristics in healthy subjects and heart failure patients.

What clinical trials is LMI 1195-101 in?

LMI 1195-101 has one completed clinical trial, registered as NCT00891241. This Phase 1 study evaluated dosimetry, biodistribution, and safety of the drug in healthy subjects and patients with heart failure. The trial enrolled 12 participants and was conducted in the United States.

Is LMI 1195-101 the same as LMI 1195?

LMI 1195-101 is the specific drug name used in clinical trials. No alternative names have been reported for this investigational compound. It is being studied under this identifier in the context of heart failure research.